The Revised Common Rule and Beyond: Opportunities for Ethical Innovation

Presented by ATLAS Institute

Friday, Oct 27
4:30 pm - 6:00 pm

Cofrin Auditorium (ATLS 100), Roser ATLAS Building

Event Details

The Revised Common Rule and Beyond: Opportunities for Ethical Innovation

This presentation will consider the 2017 revisions to the regulation for the Protection of Human Subjects in Research (the Common Rule).  We will briefly examine the history and political economy of this regulation, providing some insights into why it took more than seven years for the revisions to occur.  We will consider arguments that our ethical theory is underdeveloped with respect to important provisions of the regulation, a state of affairs that possibly affected both the process and substance of the revisions.  We will discuss what has changed, paying particular attention to implications for non-medical and “big data” research.  As research in education, sociology, economics, and other non-medical domains increasingly includes the collection of specimens and biomarker testing, such research will encounter the same fault lines and complexities in the regulation as biomedical research.  Finally, we note that some research involving humans, their specimens, or their data is not regulated under the Common Rule, but can still raise important ethical concerns.  In such situations, researchers and their institutions have opportunities to develop novel processes for ethics oversight and participant protection.  We will conclude by discussing some proposals for innovative research governance and some barriers to implementing these proposals.


Pilar Ossorio, Ph.D., JD, is Professor of Law and Bioethics at the University of Wisconsin-Madison (UW) and the Ethics Scholar-in-Residence at the UW-affiliated Morgridge Institute for Research.  She is co-Director of the Law and Neuroscience Program, leader of the Ethics Core for UW’s Big Data Center (CPCP), and director of UW’s Research Ethics Consultation Service.  In 2016, she completed her service on the U.S. Department of Health and Human Service’s Secretary’s Advisory Committee on Human Research Protections.  She currently serves on the National Heart Lung and Blood Advisory Council, the Ethics Committee of the American Society of Gene and Cell Therapy, and the Ethics Committee of the American Association of Anthropological Genetics.  She is a past member of the National Advisory Council for Human Genome Research, has served on numerous committees of the U.S. National Academies, and on many professional working groups.  She participated in or advised the International HapMap Project, the 1000 Genomes Project, and the Human Microbiome Project. Her research interests include governance data sharing in research; ethical and regulatory issues in health-related data science; regulation of medical devices; ethics of human subjects research; ethics and regulation of human microbiome research and clinical microbiome applications; and uses of race in research and medicine.  She received her Ph.D. from Stanford in Microbiology and Immunology, and her law degree from U.C. Berkeley.